Trials / Active Not Recruiting
Active Not RecruitingNCT03173248
Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation
A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination With Azacitidine in Subjects ≥ 18 Years of Age With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 146 (actual)
- Sponsor
- Institut de Recherches Internationales Servier · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult participants with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is event-free survival (EFS). The key secondary efficacy endpoints are overall survival (OS), rate of complete remission (CR), rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Participants eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An estimated 200 participants will take part in the study.
Conditions
- Newly Diagnosed Acute Myeloid Leukemia (AML)
- Untreated AML
- AML Arising From Myelodysplastic Syndrome (MDS)
- Leukemia, Myeloid, Acute
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AG-120 | Tablets administered orally |
| DRUG | Placebo | Tablets administered orally |
| DRUG | Azacitidine | Administered SC or IV |
Timeline
- Start date
- 2017-06-26
- Primary completion
- 2021-03-18
- Completion
- 2026-06-30
- First posted
- 2017-06-01
- Last updated
- 2025-11-10
- Results posted
- 2023-03-23
Locations
90 sites across 20 countries: United States, Australia, Austria, Brazil, Canada, China, Czechia, France, Germany, Israel, Italy, Japan, Mexico, Netherlands, Poland, Russia, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03173248. Inclusion in this directory is not an endorsement.